NCT04717765

Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention

Photobiomodulation With Low Level Laser in the Prevention and Treatment of Oral Lesions (Mucositis, Hyposalivation and Osteonecrosis) Resulting From Anti-neoplastic Treatment With Chemotherapy or Radiotherapy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Santiago de Compostela · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Introduction: There are several manifestations in the oral mucosa resulting from antineoplastic treatments by chemo (QT) or radiotherapy (RT). In this study we will collect the variables referring to oral mucositis (OM), radiodermatitis, osteonecrosis of the jaws (ONJ), hyposalivation and xerostomia, dysgeusia, pain, oral candidiasis (opportunistic infection), trismus, quality of life, oral hygiene. MO and hyposalivation, which are related to damage to the salivary glands, are the most common manifestations, and ONJ is the most difficult to treat. The dentist can play an important role in prevention and treatment these oral lesions, directly influencing the patient's quality of life and adherence to antineoplastic treatment. Objectives: The main objective is to evaluate the efficacy of the intervention, using LLL phototherapy and topical Vit E, in the OM. And the intervention through LLL phototherapy and LPRP in the ONJ. These interventions will be performed by dentists during antineoplastic medical treatment. Material and methods: clinical trial, randomized, with balanced randomization, single-blind (for the evaluator of the results) with 2 experimental arms and a control group, carried out in a single center. Group 1, intervention with LLL phototherapy, Group 2, intervention with application of topical Vit E and Group 3, mouthwash with 0.12% chlorhexidine (usual clinical information). 360 patients will participate in this study from the Units of Oncology Medicine, Radiotetaphic Medicine and Oral Medicine, Oral Surgery and Implantology at the University of Santiago de Compostela. The segment of the patients will be given, an initial visit and returns every day that hears the application of antineoplastic treatment for the group of LLL phototherapy, returns of 15 days, one month, three months, six months, nine months and one year. In these return visits, evaluations and questionnaires will be carried out regarding all the variables that we will collect. Predictable results: If the application of laser phototherapy or topical Vit E contributes to the cessation, reduction or improvement of the clinical evolution of the manifestation of oral lesions, these treatments could be immediately implemented in our Oral Medicine unit and could lay the foundations for its implementation in different public centers and private.

Conditions

• Oral Mucositis
• Osteoradionecrosis
• Osteonecroses, Bisphosphonate
• Osteonecrosis Due to Drugs, Jaw
• Hyposalivation
• Head and Neck Cancer
• Oral Cancer

Interventions

Type	Name	Description
DEVICE	Preventive, LLL Phototherapy and topical Vit E	Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
DEVICE	Curative, LLL Phototherapy and topical Vit E	Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
DEVICE	Preventive, LLL Phototherapy and LPRF	Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
DEVICE	Curative, LLL Phototherapy and LPRF	Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.

Timeline

• Start date: 2021-02-10
• Primary completion: 2023-02-28
• Completion: 2023-08-31
• First posted: 2021-01-22
• Last updated: 2023-11-29

Locations

1 site across 1 country: Spain